| Methods | Multicentre, randomised, parallel‐group, double‐blinded study over 10 centres in the USA with separate randomisation schemes used for each seizure type. Four treatment arms: carbamazepine, phenytoin, phenobarbitone, primidone Dates conducted: Not stated |
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| Participants | Adults with previously untreated or under‐treated simple or complex partial or secondary generalised tonic‐clonic seizures Number randomised: PHT = 165, CBZ = 155 100% partial epilepsy. 278 (87%) men. Mean age (range): 41 (18 to 82) years Range of follow‐up: 0 to 66 months |
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| Interventions | Monotherapy with PHT or CBZ. Median daily dose achieved: PHT = 400 mg/day, CBZ = 800 mg/day | |
| Outcomes | Participant retention/time to drug failure (length of time participant continued to take randomised drug) Composite scores of seizure frequency (seizure rates and total seizure control) and toxicity Incidence of side effects |
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| Notes | IPD provided for all randomised participants. All outcomes in this review calculated from IPD Funding: supported by the Veterans Adminstration Medical Research Service Cooperative Studies Program (CS 118) Conflicts of interest: None stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants randomised with stratification for seizure type. Method of randomisation not stated and not provided by authors |
| Allocation concealment (selection bias) | Unclear risk | No information provided in the publication or by study authors |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind (participants and personnel) achieved using an additional blank tablet |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Unclear if outcome assessment was blinded, no information provided |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates reported, all randomised participants analysed from IPD provided1 |
| Selective reporting (reporting bias) | Low risk | All outcomes reported or calculated with IPD provided1 |
| Other bias | Low risk | No other bias detected |